The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 9
- 主要终点
- Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
研究概览
简要总结
FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen
详细描述
FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen. The investigators also evaluate the optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven invasive pancreatic ductal carcinoma
- •Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)
- •Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
- •Patients indicated distal pancreatectomy with en bloc celiac axis resection
- •PS (ECOG) 0-1
- •≧20 years old and < 75 years old
- •First line treatment
- •The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL
- •Written informed consent to participate in this study
排除标准
- •Severe drug hypersensitivity
- •Multiple primary cancers within 5 years
- •Severe infection
- •With grade2 or more severe peripheral neuropathy
- •With intestinal paralysys, ileus
- •Interstitial pneumonia or pulmonary
- •With uncontrollable pleural effusion or ascites
- •Receiving atazanavir sulfate
- •With uncontrollable diabetes
- •With uncontrollable heart failure, angina, hypertension, arrhythmia
- •With severe psychological symptoms
- •With watery diarrhea
- •Pregnant or lactating women, or women with known or suspected pregnancy
- •Inappropriate patients for entry on this study in the judgment of the investigator
- •With UGT1A1*28 and/or UGT1A1*6 polymorphisms
研究组 & 干预措施
Optimal chemotherapy courses
Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients
干预措施: FIRINOX (Drug)
结局指标
主要结局
Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
时间窗: Up to 30 weeks.
Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
次要结局
- The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.(Up to 2 years.)
- The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.(Up to 24 weeks.)
- The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.(Up to 30 weeks.)
研究者
Hiroki Yamaue
Dean & Professor
Wakayama Medical University